A healthy microbiota requires bacterial colonization which provides the host multiple benefits including resistance to a broad spectrum of pathogens, essential nutrient biosynthesis and absorption, and immune stimulation that maintains a healthy gut epithelium and an appropriately controlled systemic immunity. In settings of dysbiosis or disrupted symbiosis, microbiota functions can be lost or deranged, resulting in increased susceptibility to pathogens, altered metabolic profiles, or induction of proinflammatory signals that can result in local or systemic inflammation or autoimmunity.
Urogenital infections such as yeast vaginitis, bacterial vaginosis, and urinary tract infection remain a major medical problem in terms of the number of women afflicted each year. These diseases affect the organs and tissues related to the reproductive system.
For all women up to the age of 40, microbiota is mainly represented by lactobacilli, and in pathological complications of the urogenital tract of women, the microbial composition of the biocoenosis is characterized by a decrease in the number of lactobacilli and their replacement by pathogenic anaerobic microorganisms. A change in the vaginal flora characterized by the decrease of lactobacilli appears to be the major factor causing the syndrome bacterial vaginosis.
Although antimicrobial therapy is generally effective at eradicating these infections, there is still a high incidence of recurrence. The patient's quality of life is affected and many women become frustrated by the cycle of repeated antimicrobial agents whose effectiveness is diminishing due to increasing development of microbial resistance.
Regular administration of a Lactobacillus strain with ability to colonize vaginal tissue can be an alternative solution for this problem. It has been shown that promising results can be obtained by using a treatment of both antibiotics and probiotics in parallel. However, it is well established in numerous studies that commercial probiotics both supplements of planktonic powders and fermented foods exert little to no health effect and lack the ability to directly deliver viable bacteria to the rectal area or the vaginal area.
There is a need for a vaginal suppositories formulation in which the probiotics are viable under the vaginal conditions, are able to adhere to the vaginal epithelial cells for a successful colonization. Moreover, it is important that such formulations are resistant to the common antibiotics used in the treatment.